Simultaneous Urgent Cardiac Surgery and Endovascular Stroke Prevention Using the Micronet-covered CGuard Stent in High Stroke Risk Patients

What this Trial Is About

Researchers are evaluating the outcomes of patients with symptomatic or critical carotid artery narrowing who also have severe coronary artery disease and/or serious heart valve disease. These patients are at risk of stroke and require urgent cardiac surgery. The study focuses on a combined approach where carotid artery treatment and cardiac surgery are done simultaneously under one anesthesia to reduce complications. This open-label, single-arm clinical registry gathers data on the safety and success of this combined treatment strategy. The treatment involves placing a MicroNet-covered stent (CGuard) in the carotid artery to prevent stroke, followed immediately by cardiac surgery such as coronary artery bypass grafting or valve repair/replacement. The procedures are performed in a hybrid operating room with backup extracorporeal circulation ready if needed. The approach is guided by a multidisciplinary team including heart and neurovascular specialists, aiming for the safest management in high-risk patients. Participants will undergo the combined procedure under single anesthesia and receive routine follow-up visits and tests over time. Researchers will assess major cardiovascular and neurological events within 30 days and up to five years after the procedure. They will also monitor procedural success, complication rates, stroke recurrence, heart symptoms, and artery function using clinical evaluations and ultrasound imaging. The study tracks long-term outcomes to understand the feasibility and safety of this simultaneous treatment approach.

Simultaneous Cardiac Surgery and Micronet-covered Stent Carotid Revascularization in High Perioperative Stroke Risk Patients